The convergence insufficiency treatment trial: Design, methods, and baseline data

Mitchell Scheiman, G. Lynn Mitchell, Susan Cotter, Marjean Kulp, Michael Rouse, Richard Hertle, Susanna Tamkins, Jeffrey Cooper, David Granet, Brian Mohney, Rachel Coulter, Michael Gallaway

Research output: Contribution to journalArticlepeer-review

78 Scopus citations

Abstract

Objective: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. We also report the clinical and demographic characteristics of patients. Methods: We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer vergence/accommodative therapy and pencil push-ups, 3) office-based vergence/accommodative therapy with home reinforcement, 4) office-based placebo therapy. Outcome data on the Convergence Insufficiency Symptom Survey (CISS) score (primary outcome), near point of convergence (NPC), and positive fusional vergence were collected after 12 weeks of active treatment and again at 6 and 12 months posttreatment. Results: The CITT enrolled 221 children with symptomatic CI with a mean age of 12.0 years (SD = +2.3). The clinical profile of the cohort at baseline was 9Δ exophoria at near (+/- 4.4) and 2Δ exophoria (+/-2.8) at distance, CISS score = 30 (+/-9.0), NPC = 14 cm (+/- 7.5), and near positive fusional vergence break = 13 Δ (+/- 4.6). There were no statistically significant nor clinically relevant differences between treatment groups with respect to baseline characteristics (p > 0.05).Conclusion: Hallmark features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a placebo treatment arm, masked outcome examinations, and the CISS score outcome measure. The baseline data reported herein define the clinical profile of those enrolled into the CITT.

Original languageEnglish (US)
Pages (from-to)24-36
Number of pages13
JournalOphthalmic Epidemiology
Volume15
Issue number1
DOIs
StatePublished - Jan 2008

Keywords

  • Computer vergence/accommodative
  • Convergence insufficiency
  • Exophoria
  • Eyestrain
  • Orthoptics
  • Pencil push-ups
  • Placebo
  • Survey
  • Symptom
  • Symptoms
  • Therapy
  • Vergence/accommodative therapy
  • Vision therapy

ASJC Scopus subject areas

  • Epidemiology
  • Ophthalmology

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